Lenvatinib, sintilimab combined interventional treatment vs bevacizumab, sintilimab combined interventional treatment for intermediate-advanced unresectable hepatocellular carcinoma

doi:10.3748/wjg.v30.i43.4620

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World Journal of Gastroenterology

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World J Gastroenterol. Nov 21, 2024; 30(43): 4620-4635
Published online Nov 21, 2024. doi: 10.3748/wjg.v30.i43.4620

Table 1 Baseline characteristics of the bevacizumab plus sintilimab plus interventional treatment and lenvatinib plus sintilimab plus interventional treatment groups before and after propensity score matching, n (%)

Variable	Before PSM			After PSM
Variable	BeSiIT (n = 32)	LeSiIT (n = 95)	P value	BeSiIT (n = 28)	LeSiIT (n = 50)	P value
Age			1.000			0.835
< 65 years	24 (75.0)	70 (73.7)		21 (75.0)	35 (70.0)
≥ 65 years	8 (25.0)	25 (26.3)		7 (25.0)	15 (30.0)
Sex			0.663			0.916
Female	4 (12.5)	17 (17.9)		4 (14.3)	9 (18.0)
Male	28 (87.5)	78 (82.1)		24 (85.7)	41 (82.0)
Hepatitis			0.212			1.000
No	4 (12.5)	4 (4.2)		3 (10.7)	4 (8.0)
Yes	28 (87.5)	91 (95.8)		25 (89.3)	46 (92.0)
Liver cirrhosis			1.000			1.000
No	9 (28.1)	27 (28.4)		8 (28.6)	14 (28.0)
Yes	23 (71.9)	68 (71.6)		20 (71.4)	36 (72.0)
AFP, ng/mL			1.000			1.000
≤ 400	18 (56.2)	52 (54.7)		15 (53.6)	28 (56.0)
> 400	14 (43.8)	43 (45.3)		13 (46.4)	22 (44.0)
Tumor size, cm			0.532			0.689
≤ 10	20 (62.5)	67 (70.5)		17 (60.7)	34 (68.0)
> 10	12 (37.5)	28 (29.5)		11 (39.3)	16 (32.0)
Tumor number			0.021^a			0.953
≤ 3	24 (75.0)	47 (49.5)		20 (71.4)	34 (68.0)
> 3	8 (25.0)	48 (50.5)		8 (28.6)	16 (32.0)
Child-Pugh			0.880			1.000
A	26 (81.2)	74 (77.9)		23 (82.1)	40 (80.0)
B	6 (18.8)	21 (22.1)		5 (17.9)	10 (20.0)
BCLC stage			0.130			0.984
B	8 (25.0)	40 (42.1)		7 (25.0)	14 (28.0)
C	24 (75.0)	55 (57.9)		21 (75.0)	36 (72.0)
ECOG PS			0.136			0.673
0	26 (81.2)	59 (62.1)		22 (78.6)	36 (72.0)
1	5 (15.6)	31 (32.6)		5 (17.9)	13 (26.0)
2	1 (3.1)	5 (5.3)		1 (3.6)	1 (2.0)
Metastasis			0.327			1.000
No	20 (62.5)	70 (73.7)		19 (67.9)	34 (68.0)
Yes	12 (37.5)	25 (26.3)		9 (32.1)	16 (32.0)
Vascular invasion			0.027^a			0.417
No	12 (37.5)	59 (62.1)		10 (35.7)	24 (48.0)
Yes	20 (62.5)	36 (37.9)		18 (64.3)	26 (52.0)

^aP value < 0.05, and it is statistically significant.

PSM: Propensity score matching; BeSiIT: Bevacizumab plus sintilimab plus interventional treatment; LeSiIT: Lenvatinib plus sintilimab plus interventional treatment; AFP: Α-fetoprotein; BCLC: The Barcelona Clinic Liver Cancer; ECOG PS: Eastern Cooperative Oncology Group Performance Status.

Table 2 Summary of the best responses, n (%)

Variable	RECIST 11			mRECIST
Variable	BeSiIT (n = 28)	LeSiIT (n = 50)	P value	BeSiIT (n = 28)	LeSiIT (n = 50)	P value
CR	0 (0.0)	0 (0.0)	-	8 (28.6)	4 (8.0)	0.016^a
PR	17 (60.7)	23 (46.0)	0.212	9 (32.1)	25 (50.0)	0.127
SD	5 (17.9)	7 (14.0)	0.651	5 (17.9)	5 (1.0)	0.319
PD	6 (21.4)	20 (40.0)	0.095	6 (21.4)	16 (32.0)	0.320
ORR	17 (60.7)	23 (46.0)	0.791	17 (60.7)	29 (58.0)	0.815
DCR	22 (78.6)	30 (60.0)	0.095	22 (78.6)	34 (68.0)	0.320

^aP value < 0.05, and it is statistically significant.

RECIST: Response Evaluation Criteria in Solid Tumors; mRECIST: Modified Response Evaluation Criteria in Solid Tumors; BeSiIT: Bevacizumab plus sintilimab plus interventional treatment; LeSiIT: Lenvatinib plus sintilimab plus interventional treatment; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; ORR: Objective response rate; DCR: Disease control rate.

Table 3 A summary of adverse reactions in the bevacizumab plus sintilimab plus interventional treatment and lenvatinib plus sintilimab plus interventional treatment groups, n (%)

Variable	BeSiIT (n = 28)		LeSiIT (n = 50)		P value
Variable	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4	Any grade	Grade 3 or 4
Thrombocytopenia	8 (28.5)	2 (7.1)	9 (18.0)	0 (0.0)	0.335	0.059
Neutropenia	4 (14.3)	0 (0.0)	9 (18.0)	1 (2.0)	0.699	0.454
Hypertension	5 (17.9)	0 (0.0)	15 (30.0)	7 (14.0)	0.306	0.047^a
Rash	4 (14.3)	0 (0.0)	8 (16.0)	1 (2.0)	0.853	0.454
Hand-foot skin reaction	4 (14.3)	0 (0.0)	8 (16.0)	1 (2.0)	0.853	0.454
Abdominal pain	1 (3.6)	0 (0.0)	3 (6.0)	1 (2.0)	0.649	0.454
Bleeding	1 (3.6)	0 (0.0)	7 (14.0)	0 (0.0)	0.167	-
Fever	2 (7.1)	0 (0.0)	0 (0.0)	0 (0.0)	0.059	-
Nausea	0 (0.0)	0 (0.0)	10 (20.0)	0 (0.0)	0.018^a	-
Decreased appetite	1 (3.6)	0 (0.0)	12 (24.0)	0 (0.0)	0.033^a	-
Diarrhea	0 (0.0)	0 (0.0)	10 (20.0)	0 (0.0)	0.018^a	-
Fatigue	2 (7.1)	0 (0.0)	16 (32.0)	2 (4.0)	0.027^a	0.290
Vomiting	0 (0.0)	0 (0.0)	8 (16.0)	0 (0.0)	0.034^a	-
Proteinuria	8 (28.5)	0 (0.0)	5 (10.0)	0 (0.0)	0.053	-
Hyperbilirubinemia	6 (21.4)	0 (0.0)	11 (22.0)	0 (0.0)	0.958	-
Elevated ALT	2 (7.1)	0 (0.0)	8 (16.0)	0 (0.0)	0.293	-
Elevated AST	6 (21.4)	0 (0.0)	13 (26.0)	1 (2.0)	0.693	0.677
Hypoalbuminemia	2 (7.1)	0 (0.0)	7 (14.0)	0 (0.0)	0.391	-

^aP value < 0.05, and it is statistically significant.

BeSiIT: Bevacizumab plus sintilimab plus interventional treatment; LeSiIT: Lenvatinib plus sintilimab plus interventional treatment; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase.

Table 4 Univariate and multivariate Cox regression analysis of clinical characteristics with progression-free survival as the dependent variable

Independent variables	Univariate		Multivariate
Independent variables	HR (95%CI)	P value	HR (95%CI)	P value
Group (LeSiIT/BeSiIT)	0.876 (0.460-1.670)	0.688
Tumor size (> 10/≤ 10 cm)	1.143 (0.597-2.187)	0.687
Tumor number (> 3/≤ 3)	0.759 (0.369-1.561)	0.453
Gender (male/female)	0.969 (0.404-2.321)	0.943
Age (years)	0.989 (0.961-1.017)	0.432
Age (≥ 65/< 65 years)	0.878 (0.425-1.813)	0.725
Etiology (yes/no)	0.559 (0.196-1.598)	0.278
Liver cirrhosis (yes/no)	0.735 (0.375-1.440)	0.369
Metastasis (yes/no)	0.767 (0.391-1.504)	0.440
Vascular invasion (yes/no)	1.041 (0.554-1.957)	0.900
Child-Pugh (B/A)	1.390 (0.655-2.951)	0.391
BCLC stage (C/B)	0.869 (0.432-1.750)	0.694
ECOG PS
0	Reference	-
1	1.562 (0.772-3.163)	0.215
2	NA	0.972
ALBI grade
1	Reference	-
2	0.668 (0.343-1.301)	0.235
3	1.643 (0.382-7.069)	0.505
AFP concentration (ng/mL)	1.000 (1.000-1.000)	0.042^a	1.000 (1.000-1.000)	0.191
AFP (> 28.0/≤ 28.0 ng/mL)	1.754 (0.830-3.708)	0.141
CEA (> 3.6/≤ 3.6 ng/mL)	1.645 (0.811-3.338)	0.168
AFCE
0	Reference	-	Reference	-
1	3.255 (1.244-8.516)	0.016^a	2.973 (1.120-7.888)	0.029^a
2	6.153 (2.011-18.821)	0.001^a	5.746 (1.865-17.708)	0.002^a

^aP value less than < 0.05, and it is statistically significant.

PFS: Progression-free survival; HR: Hazard ratios; BeSiIT: Bevacizumab plus sintilimab plus interventional treatment; LeSiIT: Lenvatinib plus sintilimab plus interventional treatment; BCLC: The Barcelona Clinic Liver Cancer; ECOG PS: Eastern Cooperative Oncology Group Performance Status; NA: Not available; ALBI: Albumin-bilirubin; AFP: Α-fetoprotein; CEA: Carcinoembryonic antigen; AFCE: Α-fetoprotein and carcinoembryonic antigen score.

Citation: Han RY, Gan LJ, Lang MR, Ren SH, Liu DM, Li GT, Liu YY, Tian XD, Zhu KW, Sun LY, Chen L, Song TQ. Lenvatinib, sintilimab combined interventional treatment vs bevacizumab, sintilimab combined interventional treatment for intermediate-advanced unresectable hepatocellular carcinoma. World J Gastroenterol 2024; 30(43): 4620-4635
URL: https://www.wjgnet.com/1007-9327/full/v30/i43/4620.htm
DOI: https://dx.doi.org/10.3748/wjg.v30.i43.4620